Regulatory Affairs (Veeva-Vault RIM)

Position Overview :

We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets. Required exposure includes

Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.

Key responsibilities :

Prepare

Variation documents and / or evaluate post-approval CMC changes

in compliance with global regulatory requirements.

Contribute to

Lifecycle Management (LCM) activities

by helping to compile and review CTD dossier modules.

Compile initial dossiers

(Modules 2 & 3)

for

US / EU / SA / WHO / ANZ / Other Countries .

Provide regulatory strategies and conduct evaluations of post-approval CMC changes considering

ICH

and country-specific guidelines.

Manage compilation and submission of variations / supplements for US / EU / SA / WHO / ANZ / Other countries.

Utilize

Veeva Vault RIM

to track queries and manage submission workflows.

Review technical documents from manufacturing sites, including :

Specifications

Batch Manufacturing Records

Process & Analytical Validations

Batch Analysis Data

Stability Data

Experience Requirement :

3+ years of experience in managing

Initial submissions ,

Variations , and full

LCM (Lifecycle management)

deliverables for the global markets.

Must have experience with Veeva Vault RIM

Proficient in ICH guidelines and regulatory guidelines for US / EU / SA / WHO / ANZ / Other countries.

Review of technical documents from manufacturing sites like of Specifications, Batch Manufacturing Records, Validations, Batch analysis data, Stability etc.

required for compilation of dossier sections / Variations.

Hands on experience in initial dossier compilation for US / EU / SA / WHO / ANZ / Other countries

(Module 2 & 3).

Experience in providing Regulatory strategies / Evaluation by performing assessment of post approval CMC Changes considering global regulatory requirements.

Compilation and submission of Variations / supplements for US / EU / SA / WHO / ANZ / Other countries as per applicable regulatory guidelines.